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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. GYNECARE MESH UNKNOWN MESH, SURGICAL

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ETHICON INC. GYNECARE MESH UNKNOWN MESH, SURGICAL Back to Search Results
Catalog Number MESHUNK
Device Problem Migration (4003)
Patient Problems Erosion (1750); Pain (1994)
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). To date the device has not been returned. If the device or further details are received at the later date a supplemental medwatch will be sent. Attempts are being made to obtain the following information. To date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent. The patient demographic info: age, weight, bmi at the time of index procedure, date and name of initial surgical procedure? the diagnosis and indication for the initial surgical procedure? other relevant patient comorbidities / concomitant medications? product code and lot number? the initial approach for the index surgical procedure? any concurrent procedure / device implantation? were there any intra-operative complications? when was the mesh erosion first noted by a physician? mesh exposure site / location, symptoms and diagnostic confirmation? describe any medical / surgical intervention for mesh erosion and severe pain including dates and surgical findings. What is physician¿s opinion as to the etiology of or contributing factors to this event? (mesh erosion and severe pain)? what is the patient's current status?.
 
Event Description
It was reported that the patient underwent a gynecological procedure on unknown date and the mesh was implanted. The patient experienced severe lower pelvic pain and erosion causing pain. The patient is unable to have intercourse. The device remains implanted. Additional information has been requested.
 
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Brand NameGYNECARE MESH UNKNOWN
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
ETHICON INC.
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key8952305
MDR Text Key156498417
Report Number2210968-2019-86456
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,other
Reporter Occupation
Type of Report Initial
Report Date 08/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberMESHUNK
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/07/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/30/2019 Patient Sequence Number: 1
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